Abstract

DEVELOPMENT AND VALIDATION OF A NOVEL CLEANING VALIDATION AND ASSAY METHOD FOR SIMULTANEOUS ESTIMATION OF ROSUVASTATIN AND FENOFIBRATE BY RPHPLC

Nazareth Celina* and Bodke Anushka

Abstract

A new, simple, precise, accurate and reproducible RP-HPLC method for cleaning validation and assay for simultaneous estimation of Rosuvastatin and Fenofibrate in tablet dosage form was developed and validated. The chromatography was carried out on AGILENTZORBAX RP-Cyano column (250mm×4.6mm,5μm) in a isocratic mode utilizing Potassium dihydrogen phosphate buffer (pH 2.5 with OPA): Methanol : Acetonitrile (45:33:22, v/v/v) as a mobile phase, at a flow rate of 1.5ml/min. Detection was carried out at 252 nm. Retention times of Rosuvastatin and Fenofibrate were 3.6 and 10.01 mins, respectively. The Beer Lambert’s law was obeyed in the concentration range 0.5-1.5μg/mL for both Rosuvastatin and Fenofibrate. The mean % recoveries at 100% and LOQ level were 96.7% and 99.0% for Rosuvastatin and 90.2% and 89.5% for Fenofibrate, respectively.

Keywords: RP-HPLC, Rosuvastatin, Fenofibrate, Cleaning Validation.